Protocol for Escitalopram and Language Intervention for Subacute Aphasia (ELISA): A randomized, double blind, placebo-controlled trial.
Protocol for Escitalopram and Language Intervention for Subacute Aphasia (ELISA): A randomized, double blind, placebo-controlled trial.
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DOI：
10.1371/journal.pone.0261474
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发表时间：
2021
期刊：
影响因子：
3.7
通讯作者：
Hillis AE
中科院分区：
文献类型：
--
作者：
Stockbridge MD;Fridriksson J;Sen S;Bonilha L;Hillis AE
在这项即将到来的多中心、前瞻性、随机、双盲的安慰剂对照试验中，我们将调查选择性5-羟色胺再摄取抑制剂艾司匹林对中风后失语症患者语言治疗的增强作用。我们假设，当与语言治疗相结合时，在语言治疗结束一周后进行的未经训练的图片命名任务(费城命名测试缩写)中，每天服用艾司匹林将比安慰剂有更大的改善。我们还将检查埃西妥普兰对语言的影响是否独立于其对抑郁症的影响，随病变位置的不同而变化，或与左半球功能连接性的增加有关。最后，我们将检查携带BDNF MET等位基因的个体是否表现出对治疗的反应减少和连接变化减少。我们预计在四年内招收88名参与者。参与者在中风后一周内接受为期90天的艾司西普兰或安慰剂治疗，并从药物治疗开始的60天开始接受15次45分钟的电脑语言治疗。然后，患者在最后一次语言治疗后的一周、五周和二十周完成全面的语言评估。ELISA是第一个评估选择性5-羟色胺再摄取抑制剂对在急性到亚急性中风后接受语言治疗的失语症患者改善语言能力的随机对照试验。试验注册：该试验在ClinicalTrials.gov NCT03843463注册。
In this forthcoming multicenter, prospective, randomized, double-blind placebo-controlled trial, we will investigate the augmentative effects of a selective serotonin reuptake inhibitor, escitalopram, on language therapy in individuals with post-stroke aphasia. We hypothesize that, when combined with language therapy, daily escitalopram will result in greater improvement than placebo in an untrained picture naming task (Philadelphia Naming Test short form) administered one week after the end of language therapy. We also will examine whether escitalopram’s effect on language is independent of its effect on depression, varies with lesion location, or is associated with increased functional connectivity within the left hemisphere. Finally, we will examine whether individuals with BDNF met alleles show reduced response to treatment and reduced changes in connectivity. We expect to enroll 88 participants over four years. Participants are given escitalopram or placebo within one week of their stroke for 90 days and receive fifteen 45-minute computer-delivered sessions of language treatment beginning 60 days from the start of drug therapy. Patients then complete a comprehensive assessment of language at one, five, and twenty weeks after the last language therapy session. ELISA is the first randomized, controlled trial evaluating the effect of a selective serotonin reuptake inhibitor on the improvement of language in people with aphasia undergoing language treatment during the acute to subacute post-stroke period. Trial registration: The trial is registered with ClinicalTrials.gov NCT03843463.
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影响因子：
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